Assay development solutions
Unlock the full potential of your drug discovery with our cutting-edge assay development services. From development to screening, we're here to accelerate your path to success.
Empower your research with tailored assay solutions
Assay development is a critical component of drug discovery. Well-developed and characterized assays drive successful discovery campaigns. We offer expertise in developing fit-for-purpose assays across multiple formats and target classes, utilizing advanced instrumentation to deliver customized solutions.
Why partner with Enzene?
We are a global Continuously Innovative Development and Manufacturing Organization (CIDMO), dedicated to changing the paradigm by which affordable biologic and biosimilar medicines are brought to market. Since Enzene’s inception, our innovative agility has enabled us to continually introduce transformative processes in biologics manufacturing that significantly increase product yields of complex biologics and monoclonal antibodies (mAbs) while reducing the manufacturing footprint and the cost of production.
Game-changing innovation is only the beginning, though. We are Enzene, and that means that our values of innovation, entrepreneurship, respect, candor, excellence, and integrity underscore everything we do from project management and communications to teamwork and ideation. To us, true partnership is about driving biotech innovation while doing so in a way that develops long-lasting trusted partnerships.
Our approach
Our scientific and client-centric approach ensures timely project delivery, while our cutting-edge technological capabilities offer versatility and ease in decision-making.
We focus on key factors for optimal assay development:
- Assay format and technology selection
- Reagent quality and availability
- Sensitivity, specificity and robustness
- Reproducibility and scalability
- Signal-to-noise ratio optimization
- Appropriate controls to minimize false results
Our expertise in assay development
For cell-based assays, we carefully consider:
- Cell line selection and disease relevance
- Understanding of cell signaling pathways
- Assay stability across multiple passages
Our solutions
With these capabilities in mind, we offer a comprehensive range of solutions designed to support your specific research needs:
1 Immunophenotyping
Assess surface expression of key marker proteins on immune cells
Identify and characterize immune cell subtypes and differentiation
Measure cytokine release to assess cellular function
Evaluate in vitro immunogenicity of drug substance (DS) and drug product (DP) in assays measuring innate as well as adaptive immunity
2 Biomarker discovery, screening and characterization
- Utilize a multi-omics approach for biomarker identification
- Employ techniques like immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), microarrays, proteomics and next-generation sequencing (NGS)
- Intelligent, fit-for-purpose multi-omics approach using intelligently designed combinations of various platform technologies to yield a potential biomarkers (or molecular indicators) — extensively characterized using orthogonal assays in various models
3 Cytokine and growth factor profilling
- Use Luminex xMAP Technology for multiplexed analysis
- Applications in disease diagnosis, therapeutic development to evaluate efficacy and mode of action (MOA) of novel drugs and research for enhancing our understanding about biological processes and cellular interactions
4 In vitro immunogenicity assays
- Assess immunogenic potential of drug substance/product
- Evaluate innate and adaptive immune responses in human peripheral blood mononuclear cells (PBMCs)
- All assays are accompanied by set of known allergens/immunogens (PAMPs) that activate innate immune arms via specific TLRs/PRRs
5 Immunogenicity, pharmacokinetics and pharmacodynamics (PK/PD)
- Evaluate drug concentration and time course in biological samples (pharmacokinetics) and immunogenicity anti-drug antibodies (ADA) of biologics
- Measure ADA formation and assess the triggering of the patient immune system by biologics
- Measure pharmacodynamic effects based on drug mechanism of action. This could be a soluble biomarker such as serum protein or cytokine, or a cellular marker such as protein/DNA modification (phosphorylation, acetylation, methylation, etc.)
- Assay sensitivity, specificity, precision and accuracy and matrix interference are key aspects considerations
- PK and immunogenicity data together provide a comprehensive understanding of drug behavior in vivo
6 Autoantibody detection
- Screen for autoantibodies related to autoimmune diseases
- Detect common autoantibodies like anti-nuclear antibodies (ANA), anti-dsDNA, anti-SSA/Ro, antibodies against nuclear proteins, certain enzymes and ribosomal proteins
7 Genomic and transcriptomic assays
- Screen for autoantibodies related to autoimmune diseases
- Detect common autoantibodies like anti-nuclear antibodies (ANA), anti-dsDNA, anti-SSA/Ro, antibodies against nuclear proteins, certain enzymes and ribosomal proteins
8 Effector function assays
- Design assays based on drug-target mechanism of action
- Offer effector assays (ADCC, ADCP, CDC, Fc receptor binding)
- Provide screening assays (binding, functional, phenotypic, cytotoxicity)
- Orthogonal assays for additional characterization
9 Custom assay development
- Design assays aligned with specific research/client needs
- Develop cell-free and cell-based phenotypic assays
- Create surrogate assays mimicking cell signaling
- Generate custom reporter gene cell lines
10 Data analysis and interpretation
- Strong internal due diligence ensures concordance with assay criteria and QC parameters
- Provide data visualization and statistical evaluation
- Interpret results to facilitate decision-making
